The purpose of the study is to evaluate the safety of NVG-2089 and to evaluate how well patients respond to this investigational treatment. NVG-2089 is a new drug that is being developed for treating patients with ITP. NVG-2089 is designed to mimic the effects of a protein called IVIg. NVG-2089 is designed to help the immune system by attaching (binding) to certain receptors in the body and activating them, which helps reduce inflammation and supports how the immune system works.
Males and female participants, age 18 to 80 years at time of screening.
Diagnosis of persistent (>3 months and ≤12 months), or chronic (>12 months) primary ITP. If the participant has received prior treatment for ITP, they must have a history of response to at least one previous therapy (defined as increase in platelet count to ≥ 50,000 cells/mm3 with an increase of ≥ 20,000 cells/mm3 relative to platelet count prior to treatment).
Asymptomatic or with minor mucocutaneous bleeding AND platelet count of ≤50,000 cells/mm3, measured on 2 occasions at least 5 days apart during the screening period.
(For US only) If at least one screening platelet count >30,000 cells/ mm3 and <50,000 cells/mm3, the participant must be on at least 1 other treatment for ITP with insufficient response as evidenced by platelet count <50,000 cells/ mm3.
Secondary forms of ITP (e.g., ITP secondary to infection, autoimmune diseases, lymphoproliferative diseases and medications).
History of splenectomy.
History of malignancy, unless the participant received treatment with curative intent. Participants with fully excised non-melanoma skin cancer or cervical cancer are allowed.
History of solid organ transplant.
Single group
NVG-2089
DrugStudy Treatment
Evaluate incidence, nature and severity of Treatment Emergent Adverse Events (TEAEs)
Evaluate incidence, nature and severity of Serious Adverse Events (SAEs)
Percent of participants achieving a response.
* For participants with a baseline platelet count between \< 30,000 cells/mm3, a response is defined as a doubling of the baseline platelet count or a platelet count of ≥50,000 cells/mm3; * For participants with a baseline platelet count ≥ 30,000 t cell/mm3, a response is defined as an increase in the baseline platelet count to \>20,000 cells/mm3;
Click on the lead sponsor to view all of their trials.
